ACP-204 in Adults With Alzheimer's Disease Psychosis

April 15, 2024 updated by: ACADIA Pharmaceuticals Inc.

A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP

  • Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.
  • Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.

All 3 substudies will be analyzed independently of each other.

Each substudy individually will consist of a screening period (up to 42 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1074

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center, Inc.
      • Costa Mesa, California, United States, 92626
        • Recruiting
        • ATP Clinical Research
      • Fresno, California, United States, 93710
        • Recruiting
        • Neuro-Pain Medical Center
      • Garden Grove, California, United States, 92844
        • Recruiting
        • National Institute of Clinical Research
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Arrow Clinical Trials
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • New Life Medical Research Center Inc.
      • Miami, Florida, United States, 33176
        • Recruiting
        • Visionary Investigators Network
      • Miami, Florida, United States, 33122
        • Recruiting
        • Premier Clinical Research Institute, Inc.
      • Miami, Florida, United States, 33165
        • Recruiting
        • MediClear Medical & Research Center, Inc.
      • Miami, Florida, United States, 33032
        • Recruiting
        • Homestead Associates in Research Inc.
      • Miami, Florida, United States, 33165
        • Recruiting
        • Future Care Solution, LLC
      • Miami, Florida, United States, 33135
        • Recruiting
        • Verus Clinical Research
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Quantum Clinical Trials
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Floridian Neuroscience Institutue
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Neuroscience Research Institute
    • Illinois
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Revive Research Institute, Inc.
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Alivation Research, LLC
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurologic Institute
      • Bronx, New York, United States, 10466
        • Recruiting
        • Regional Neurological Associates
      • Rochester, New York, United States, 14618
        • Recruiting
        • Finger Lakes Clinical Research
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Recruiting
        • Insight Clinical Trials LLC
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Valley Medical Research
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Recruiting
        • Abington Neurological Associates
    • Texas
      • Houston, Texas, United States, 77074
        • Recruiting
        • Clinical Trial Network LLC
      • Stafford, Texas, United States, 77477
        • Recruiting
        • R & H Clinical Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting
  • Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria
  • Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)
  • Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD
  • Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD
  • Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association
  • MMSE score ≥6 and ≤24
  • Psychotic symptoms for at least 2 months
  • Lives in a stable place of residence and there are no plans to change living arrangements
  • Has a designated study partner/caregiver
  • Able to complete all study visits with a study partner/caregiver
  • Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable

Exclusion Criteria:

  • Requires treatment with a medication prohibited by the protocol
  • Is in hospice and receiving end-of-life palliative care, or has become bedridden
  • Requires skilled nursing care
  • Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia
  • Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope
  • Atrial fibrillation
  • Symptomatic orthostatic hypotension
  • Protocol-defined exclusionary clinical laboratory findings

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACP-204 30 mg
Administration once daily at approximately the same time of day, with or without food
Drug: ACP-204
ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
Experimental: ACP-204 60 mg
Administration once daily at approximately the same time of day, with or without food
Drug: ACP-204
ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
Placebo Comparator: Placebo
Administration once daily at approximately the same time of day, with or without food
Drug: Placebo
ACP-204 matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)
Time Frame: From baseline to Week 6
The SAPS-H+D subscales are a measure of two psychotic symptoms: hallucinations and delusions. The SAPS-H+D total score is the sum of the scores of the Hallucinations and Delusions subscales. The hallucinations domain score (SAPS-H) is the sum of the 7 hallucinations item scores, and the delusions domain core (SAPS-D) is the sum of the 13 delusions item scores.
From baseline to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score
Time Frame: Week 6
The CGI-I scale is a clinician-rated, 7-point scale used to rate the improvement in symptoms at the time of assessment, relative to the symptoms at Baseline. The CGI-I-ADP scale is the CGI-I scale applied in the ADP context, in which hallucinations and delusions are the symptoms of interest.
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ACADIA Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACP-204-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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